U.S. Food and Drug Administration Commissioner Dr. Stephen M. Hahn testifies before the House Energy and Commerce Committee on the Trump Administration’s response to the COVID-19 pandemic, at Capitol Hill, Washington, DC on June 23, 2020.
Kevin Dietsch | Pool via Reuters
The Food and Drug Administration would authorize a coronavirus vaccine as long as it is safe and at least 50% effective, the agency’s commissioner Dr. Stephen Hahn said Thursday.
“We all want a vaccine tomorrow. That is not realistic. And we all want a vaccine that is 100% effective. Again, unrealistic,” Hahn said in an interview with Dr. Howard Bauchner of the Journal of the American Medical Association. “But we said 50%, and the reason was because we felt it was a reasonable floor given the pandemic.”
He added that the minimum requirement of 50% effectiveness also helped give vaccine manufacturers guidance on how to design their clinical trials. Moderna and Pfizer sent their vaccine candidates to phase three trials earlier this week, with the goal of recruiting some 30,000 participants to demonstrate that the vaccines are safe and effective in a large population.
Fortunately, Hahn said, the vaccine or vaccines that do end up being licensed will prove to be more than 50% effective, but it is possible that the US may end up with a vaccine that, on average, reduces a person’s risk of a Covid- 19 infection in only 50%.
“We really feel that that had to be the floor,” he said, adding that “it has been hit by medical groups.” “But for the most part, I think, infectious disease experts have agreed that that’s a reasonable floor, of course, hoping that the actual effectiveness is greater.”
Dr. Anthony Fauci has said that he expects the vaccine to have an efficacy rate of at least 60%, which means that, on average, the vaccine reduces the risk of Covid-19 infection by 60%.
“Obviously, we would like to see it much, much higher. But 60% is the standard that is made for the cut. That is not unusual,” he said Monday. “I would like to see the highest percentage we could get.”
Hahn added Thursday that if a vaccine is not safe, the FDA will not authorize it, regardless of how effective it appears to be.
“If we reach 50% but it is not safe, for me, it is not a vaccine that we can authorize,” he said. “We are going to analyze that security data very, very, very carefully and we will be transparent, Howard, about what we have seen.”
He said the FDA is using new strategies and technology to streamline data collection from clinical trial participants to collect safety data more quickly and frequently. The FDA will also continue to monitor the safety of vaccines after they are licensed and administered to the public, he said.
“We cannot have a situation where people lose confidence in the FDA and in the clinical trial process,” he said. “That would be a mistake for all of us.”
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